Manufacturing Engineer

Our Work Matters

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.

The Impact You Will Make

The Manufacturing Process Engineer plays a crucial role in ensuring consistent high performance of manufacturing equipment and processes. This “hands on” position owns the manufacturing process and focuses on the performance of manufacturing operations to ensure quality, improve performance and reduce line scrap / waste.

Essential Job Functions

• Serve as the technical lead and owner of manufacturing equipment and process systems.
• Efficiently manage and coordinate manufacturing technical processes and functions at the site in support of technical projects.
• Lead projects or participate on project teams to develop the manufacturing process for new products and implement improvements to existing manufacturing processes.
• Investigate process deviations on the manufacturing floor using structured Six Sigma-based methods
• Collaborate with Operations, Quality Assurance (QA), Operational Excellence (OPEX), Maintenance and other internal experts to develop quality investigations, determine root causes, and implement corrective and preventive actions (CAPA).
• Develop and execute manufacturing protocols and machine trials as needed to support Compliance and Continuous Improvement projects.
• Facilitate Operations equipment and process ownership by being the primary internal technical training resource for Operations Management and production floor teams.
• Provide support to manufacturing staff on the production floor to ensure smooth scale-ups and technical transfers.
• Identify and implement cost-saving initiatives, with a specific focus on quality and efficiency improvements.
• Lead technical improvement projects aimed at achieving "zero defects," enhancing equipment reliability, and maximizing utilization.
  
  

Basic Qualifications

• Bachelor’s degree (or higher) in Process Engineering, Industrial Engineering, Chemical Engineering, Mechanical Engineering, Electrical Engineering, or a Science-related field.
• Completion of a recognized certificate program or specialized courses in process engineering, demonstrating comprehensive knowledge and practical skills in process design, optimization, control systems, safety considerations, and project management.
• 2 years of experience in Pharmaceutical or Combination Product/Medical Device Manufacturing
• Experience leading engineering improvement projects
• Familiarity with Fault Tree Analysis.
• Experience with risk management files and maintenance of pFMEAs
• Understanding of Design Control regulations
• Knowledge of electro-mechanical principles and automated machine and visual process control.
• Ability to present technical information clearly and communicate effectively at all levels of the organization.
  
  

California residents should review our Notice for California Employees and Applicants before applying.

Equal Opportunity Employer

Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

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